1. Objections to the IDSA guidelines for diagnosis of LD and chronic LB:

- Seronegativity is frequent in LD and does not rule out a chronic persistent

Borrelia burgdorferi (Bb) infection (1-18).

- The differential diagnosis between multiple sclerosis and neuroborreliosis based on CSF and serum analysis is not possible in at least 25% of cases (9-11, 21).

- Peripheral neuropathy is not rare but occurs in over 20% of LD cases (22-

25).

- So-called two-tier testing is not suitable to diagnose LB, particularly in the late phase, for the following reasons:

o The test methods available on the market are not standardized with respect to their diagnostic value.

o The sensitivity of ELISA and IFA screening tests varies from 50% to

70%.

o The sensitivity of the Lyme Western blot is around 10% higher than that of the screening test.

o This difference in sensitivity means that there is a risk that the screening test will be negative whereas the Western blot shows positive, and the diagnosis of LD will be missed.

o Neither the screening test nor the Western blot can rule out infection with Bb, i.e., there is a problem of seronegativity (based on the screening test and Western blot) even though the illness persists and has been confirmed by identification of the pathogenic agent (1-18).

2. Objections to the IDSA guidelines for treatment of LD and chronic LB:

- In Europe, LD is often associated with generalized dissemination throughout the entire body, including involvement of the central nervous system (CNS). Treatment should therefore be carried out with antibiotics that penetrate the CNS, irrespective of the various manifestations of the illness (arthritis, neuroborreliosis, neuropathy, acrodermatitis, carditis, encephalopathy).

- The oral antibiotics recommended by IDSA, namely low-dose doxycycline, amoxicillin and cefuroxime, do not penetrate the CNS; in contrast, minocycline, gemifloxacin and intravenous third-generation cephalosporins yield high concentrations in CSF above the minimal inhibitory concentration (MIC) for Bb (19).

- Contrary to the negative opinion of IDSA, the following antibiotics and methods of treatment have proven to be advantageous: carbapenems, ketolides and gemifloxacin (19); pulsed-dosing (20).

- The antibiotic treatment of EM displays a therapeutic failure rate of at least

10% (15, 41, 45, 47, 67-74).

- Bb could still be identified in the skin even after multiple antibiotic treatments with ceftriaxone, doxycycline and cefotaxime (47-49).

- The resistance of Bb to numerous antibiotics has been proven (61).

3. Objections to the proposed IDSA definition of “post-Lyme syndrome”:

- Antibiotic treatment according to the IDSA guidelines does not guarantee elimination of Bb.

- Subjective complaints may reflect ongoing infection with Bb rather than a different illness (PLS).

- The disease situation described by Steere et al (26) as “minor signs and symptoms” and by Bujak (27) as “post-Lyme syndrome” represents serious discomfort for affected patients that is comparable to decompensated cardiac insufficiency, degenerative joint diseases, pronounced diabetes mellitus or a condition after a myocardial infarction according to Klempner et al (2).

- The following facts suggest the existence of chronic LB due to persistent Bb infection:

2. Objections to the IDSA guidelines for treatment of LD and chronic LB:

- In Europe, LD is often associated with generalized dissemination throughout the entire body, including involvement of the central nervous system (CNS). Treatment should therefore be carried out with antibiotics that penetrate the CNS, irrespective of the various manifestations of the illness (arthritis, neuroborreliosis, neuropathy, acrodermatitis, carditis, encephalopathy).